Recall Z-2156-2014 ยท LFL Instrument, Ultrasonic Surgical
Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
| Date | Aug 7, 2014 (initiated Jun 24, 2014) |
| Status | Terminated |
| Reason | The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip. |
| Root cause | Labeling design |
| Action | The firm sent Medical Device Upgrade Notification letters dated July 11, 2014 to their customers. |
| Quantity | 2,460 units |
| Distribution | Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010309 | SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR Mutoh America Co., Ltd., Apr 18, 2001 |